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The Effect of Protandim Supplementation on Oxidative Damage and Athletic Performance

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ClinicalTrials.gov Identifier: NCT02172625
Recruitment Status : Completed
First Posted : June 24, 2014
Results First Posted : January 9, 2017
Last Update Posted : January 9, 2017
Sponsor:
Information provided by (Responsible Party):
Gerald S Zavorsky, PhD, University of Louisville

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Supportive Care
Condition Oxidative Stress
Interventions Dietary Supplement: Protandim Dietary Supplement
Other: Placebo Group
Enrollment 40
Recruitment Details 40 subjects were recruited. 2 subjects were excluded. 1 not meeting inclusion criteria, and 1 declined to participate. Thus, 38 subjects were randomized into either the Protandim Group (n = 19) or Placebo Group (n = 19)
Pre-assignment Details  
Arm/Group Title Sugar Pill Protandim Dietary Supplement
Hide Arm/Group Description

Corn starch and food coloring is the placebo comparator. Each subject will ingest 675 mg (1 pill) per day of the placebo comparator

Protandim Dietary Supplement: This was a randomized, block design, controlling for 5-km performance and sex. Subjects were given either 675 mg per day (1 pill per day) of Protandim for 90 days, or a 675 mg per day (1 pill per day) placebo (sugar pill). Subjects ran a 5-km time trial before and after the supplementation period. Blood samples were taken pre and post supplementation.

Each subject will ingest 675 mg per day (1 pill) of Protandim for about 90 days. Each pill contains 5 botanicals (Bacoba extract 150 mg, milk thistle 225mg, ashwaganda 150 mg, green tea 75 mg, turmeric 75 mg).

Protandim Dietary Supplement: This was a randomized, block design, controlling for 5-km performance and sex. Subjects were given either 675 mg per day (1 pill per day) of Protandim for 90 days, or a 675 mg per day (1 pill per day) placebo (sugar pill). Subjects ran a 5-km time trial before and after the supplementation period. Blood samples were taken pre and post supplementation.

Period Title: Overall Study
Started 19 19
Completed 19 16
Not Completed 0 3
Reason Not Completed
Adverse Event             0             1
Pregnancy             0             1
car accident             0             1
Arm/Group Title Sugar Pill Protandim Dietary Supplement Total
Hide Arm/Group Description

Corn starch and food coloring is the placebo comparator. Each subject will ingest 675 mg (1 pill) per day of the placebo comparator

Protandim Dietary Supplement: This was a randomized, block design, controlling for 5-km performance and sex. Subjects were given either 675 mg per day (1 pill per day) of Protandim for 90 days, or a 675 mg per day (1 pill per day) placebo (sugar pill). Subjects ran a 5-km time trial before and after the supplementation period. Blood samples were taken pre and post supplementation.

Each subject will ingest 675 mg per day (1 pill) of Protandim for about 90 days. Each pill contains 5 botanicals (Bacoba extract 150 mg, milk thistle 225mg, ashwaganda 150 mg, green tea 75 mg, turmeric 75 mg).

Protandim Dietary Supplement: This was a randomized, block design, controlling for 5-km performance and sex. Subjects were given either 675 mg per day (1 pill per day) of Protandim for 90 days, or a 675 mg per day (1 pill per day) placebo (sugar pill). Subjects ran a 5-km time trial before and after the supplementation period. Blood samples were taken pre and post supplementation.

Total of all reporting groups
Overall Number of Baseline Participants 19 19 38
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 19 participants 19 participants 38 participants
35  (8) 34  (6) 34  (7)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants 19 participants 38 participants
Female
10
  52.6%
8
  42.1%
18
  47.4%
Male
9
  47.4%
11
  57.9%
20
  52.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 19 participants 19 participants 38 participants
19 19 38
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 19 participants 19 participants 38 participants
19 19 38
Weight  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 19 participants 19 participants 38 participants
64.6  (11.1) 68.1  (11.4) 66.4  (11.2)
Fasting Blood Glucose  
Mean (Standard Deviation)
Unit of measure:  mg/dL
Number Analyzed 19 participants 19 participants 38 participants
89  (9) 90  (5) 90  (7)
1.Primary Outcome
Title 5-km Running Time
Hide Description 5-km running performance time was measured twice at the beginning of the study, and then once post-supplementation. The best 5 km time from both initial sessions was counted as the baseline 5-km time. The full report can be found here: http://dx.doi.org/10.1371/journal.pone.0160559
Time Frame Baseline and 88 (SD 4) days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Runners from the Louisville, KY, USA, community
Arm/Group Title Sugar Pill Protandim Dietary Supplement
Hide Arm/Group Description:
Corn starch and food coloring is the placebo comparator. Each subject ingested 675 mg (1 pill) per day of the placebo comparator
Each subject ingested 675 mg per day (1 pill) of Protandim for about 90 days. Each pill contains 5 botanicals (Bacopa extract 150 mg, milk thistle 225mg, ashwagandha 150 mg, green tea 75 mg, turmeric 75 mg).
Overall Number of Participants Analyzed 19 16
Mean (Standard Deviation)
Unit of Measure: minutes
Baseline 20.2  (2.0) 20.4  (2.3)
88 days Post-supplementation 20.0  (2.1) 20.1  (2.7)
2.Primary Outcome
Title Lipid Peroxides (TBARS)
Hide Description Lipid peroxides (TBARS) is a measure of oxidative damage in the blood. The full report can be found here: http://dx.doi.org/10.1371/journal.pone.0160559
Time Frame Baseline, 30 days, 57 days, and 88 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The values reported here are the values in a fasted state. The full report can be found here: http://dx.doi.org/10.1371/journal.pone.0160559
Arm/Group Title Sugar Pill Protandim Dietary Supplement
Hide Arm/Group Description:
Corn starch and food coloring is the placebo comparator. Each subject ingested 675 mg (1 pill) per day of the placebo comparator
Each subject ingested 675 mg per day (1 pill) of Protandim for about 90 days. Each pill contained 5 botanicals (Bacopa extract 150 mg, milk thistle 225mg, ashwagandha 150 mg, green tea 75 mg, turmeric 75 mg).
Overall Number of Participants Analyzed 19 16
Mean (Standard Deviation)
Unit of Measure: umol/L
TBARS, rest, baseline 7.8  (1.8) 8.1  (2.0)
TBARS, rest, 30 (SD 2) days post-supplementation 8.2  (2.2) 8.0  (3.5)
TBARS, rest, 57 (SD 2) days post-supplementation 8.0  (2.6) 9.5  (5.1)
TBARS, rest, 88 (SD 4) days post-supplementation 7.9  (4.0) 7.1  (2.3)
TBARS, 10-min post-exercise, Baseline 8.5  (2.5) 8.5  (2.4)
TBARS, 10-min post-exercise, 88 days post-suppl 6.8  (2.5) 7.5  (2.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sugar Pill, Protandim Dietary Supplement
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter week-to-week coefficient of variation %
Estimated Value 26
Estimation Comments This was the week-to-week coefficient of variation (CV) obtained at baseline over two different weeks in a fasted state measured at rest.
3.Secondary Outcome
Title Glutathione Peroxidase (GPX)
Hide Description Blood was collected in vacuum-sealed tubes designed to contain and preserve specimens in a manner appropriate for their respective analysis and shipped to Geneva Diagnostics for analysis using proprietary methodology (Oxidative Stress Analysis 2.0, Blood). Genova Diagnostics is a global, fully accredited clinical laboratory, located in Asheville, NC [Licensed by Clinical Laboratory Improvement Amendments (CLIA) Certification number #34D0655571]. Glutathione peroxidase (GPX). This is a measure of glutathione peroxidase activity in red blood cell lysates sampled fromwhole blood. The level of GPX in the sample is determined spectrophotometrically based on the ability of the compound to catalyze a reduction reac- tion in the presence of glutathione. The change in the absorption level of the substrate is then utilized to determine the level of GPX present in the sample. The result is expressed as units of GPX relative to the gram amount of hemoglobin in the sample.
Time Frame Baseline, 30 days, 57 days, and 88 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sugar Pill Protandim Dietary Supplement
Hide Arm/Group Description:
Corn starch and food coloring is the placebo comparator. Each subject ingested 675 mg (1 pill) per day of the placebo comparator
Each subject ingested 675 mg per day (1 pill) of Protandim for about 90 days. Each pill contains 5 botanicals (Bacoba extract 150 mg, milk thistle 225mg, ashwaganda 150 mg, green tea 75 mg, turmeric 75 mg).
Overall Number of Participants Analyzed 19 16
Mean (Standard Deviation)
Unit of Measure: U/g Hb
GPX, fasted, rest, baseline 28.4  (7.4) 27.8  (4.6)
GPX, rest, 30 (SD 2) days post-supplementation 28.7  (7.2) 27.5  (4.0)
GPX, rest, 57 (SD 2) days post-supplementation 29.0  (5.3) 28.6  (4.1)
GPX, rest, 88 (SD 4) days post-supplementation 31.9  (7.8) 31.0  (4.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sugar Pill, Protandim Dietary Supplement
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter week-to-week coefficient of variation %
Estimated Value 15
Estimation Comments This was the week-to-week coefficient of variation (CV) obtained at baseline over two different weeks in a fasted state measured at rest.
4.Secondary Outcome
Title Quality of Life as Assessed by the World Health Organization Quality of Life Questionnaire (Brief)
Hide Description

This is a questionnaire that assessed quality of life across 4 domains over the supplementation period.

  1. Physical Health domain: Scores range from 7 (lowest) to 35 (best, most favorable).
  2. Psychological Health Domain: Scores range from 6 (lowest) to 30 (best, most favorable).
  3. Social Relationships Domain: Scores range from 3 (lowest) to 15 (best, most favorable).
  4. Environment Domain: Scores range from 8 (lowest) to 40 (best, most favorable).
Time Frame Baseline, 30 days, 57 days, and 88 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Healthy community runners.
Arm/Group Title Placebo Group Protandim Group
Hide Arm/Group Description:

Corn starch and food coloring is the placebo comparator. Each subject ingested 675 mg (1 pill) per day of the placebo comparator

Protandim Dietary Supplement: This was a randomized, block design, controlling for 5-km performance and sex. Subjects were given either 675 mg per day (1 pill per day) of Protandim for 90 days, or a 675 mg per day (1 pill per day) placebo (sugar pill). Subjects ran a 5-km time trial before and after the supplementation period. Blood samples were taken pre and post supplementation.

Each subject ingested 675 mg per day (1 pill) of Protandim for about 90 days. Each pill contains 5 botanicals (Bacopa extract 150 mg, milk thistle 225mg, ashwagandha 150 mg, green tea 75 mg, turmeric 75 mg).
Overall Number of Participants Analyzed 19 19
Mean (Standard Deviation)
Unit of Measure: units on a scale
Physical Health, Baseline 27.6  (5.2) 27.2  (4.4)
Physical Health, 30 (2) days post-supplementation 28.0  (4.5) 24.3  (4.6)
Physical Health, 57 (2) days post-supplementation 27.1  (4.8) 27.0  (4.6)
Physical Health, 88 (4) days post-supplementation 28.4  (4.1) 27.1  (4.8)
Psychological Health, Baseline 22.8  (5.2) 22.4  (3.9)
Psychological Health 30 days post-supplementation 23.4  (4.5) 22.7  (4.4)
Psychological Health 57 days post-supplementation 23.4  (4.6) 22.5  (4.2)
Psychological Health, 88 days post-supplementation 23.6  (4.9) 22.2  (4.4)
Social Health, Baseline 11.9  (3.7) 12.2  (2.2)
Social Health, 30 days post-supplementation 12.1  (2.1) 12.5  (2.1)
Social Health, 57 days post-supplementation 12.3  (2.9) 12.1  (2.1)
Social Health, 88 days post-supplmentation 12.6  (3.0) 11.9  (2.5)
Environmental Health, Baseline 34.6  (6.2) 32.6  (4.0)
Environmental Health, 30 days post-supplmentation 32.1  (5.0) 33.1  (4.7)
Environmental Health, 57days post-supplementation 32.3  (4.8) 32.1  (5.1)
Environmental Health, 88 days post-supplementation 35.5  (4.6) 32.2  (4.8)
5.Secondary Outcome
Title Total Antioxidant Capacity (TAC)
Hide Description Blood was collected in vacuum-sealed tubes designed to contain and preserve specimens in a manner appropriate for their respective analysis and shipped to Geneva Diagnostics for analysis using proprietary methodology (Oxidative Stress Analysis 2.0, Blood). Genova Diagnostics is a global, fully accredited clinical laboratory, located in Asheville, NC[Licensed by Clinical Laboratory Improvement Amendments (CLIA) Certification number #34D0655571]. Total antioxidant capacity (TAC). The TAC measures the overall collective power of the blood to neutralize free radicals. Specifically, the TAC assay measures the antioxidant capacity of a serum sample via the ability of the antioxidants within the sample to neutralize a spectrophotometrically active compound that is optically active when oxidized. The decrease in color intensity of the compound when compared to the standard, Trolox, under the same reaction conditions is equivalent to the serum antioxidant capacity of the serum sample.
Time Frame Baseline and 88 (SD 4) days. All pre-exercise values.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Runners from the Louisville, KY, USA, community
Arm/Group Title Sugar Pill Protandim Dietary Supplement
Hide Arm/Group Description:
Corn starch and food coloring is the placebo comparator. Each subject ingested 675 mg (1 pill) per day of the placebo comparator
Each subject ingested 675 mg per day (1 pill) of Protandim for about 90 days. Each pill contains 5 botanicals (Bacopa extract 150 mg, milk thistle 225mg, ashwagandha 150 mg, green tea 75 mg, turmeric 75 mg).
Overall Number of Participants Analyzed 19 16
Mean (Standard Deviation)
Unit of Measure: mmol/L
Baseline 0.86  (0.06) 0.86  (0.07)
88 days Post-supplementation 0.80  (0.06) 0.80  (0.07)
6.Secondary Outcome
Title Whole Blood Glutathione Content (GSH)
Hide Description Blood was collected in vacuum-sealed tubes designed to contain and preserve specimens in a manner appropriate for their respective analysis and shipped to Geneva Diagnostics for analysis using proprietary methodology (Oxidative Stress Analysis 2.0, Blood). Genova Diagnostics is a global, fully accredited clinical laboratory, located in Asheville, NC [Licensed by Clinical Laboratory Improvement Amendments (CLIA) Certification number #34D0655571]. The total whole blood glutathione assay is designed to measure the level of glutathione in whole blood. The samples is first completely lysed and proteins are precipitated. The supernatant is then reduced and combined with a spectrophotometrically reactive compound which generates a detectable absorption peak. When compared to known concentrations of glutathione under the same reaction conditions a determination of glutathione levels in blood is determined.
Time Frame Baseline and 88 (SD 4) days. All pre-exercise values.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Runners from the Louisville, KY, USA, community
Arm/Group Title Sugar Pill Protandim Dietary Supplement
Hide Arm/Group Description:
Corn starch and food coloring is the placebo comparator. Each subject ingested 675 mg (1 pill) per day of the placebo comparator
Each subject ingested 675 mg per day (1 pill) of Protandim for about 90 days. Each pill contains 5 botanicals (Bacopa extract 150 mg, milk thistle 225mg, ashwagandha 150 mg, green tea 75 mg, turmeric 75 mg).
Overall Number of Participants Analyzed 19 16
Mean (Standard Deviation)
Unit of Measure: umol/L x 10
Baseline 102  (19) 103  (13)
88 days Post-supplementation 96  (18) 104  (30)
7.Secondary Outcome
Title Superoxide Dismutase (SOD)
Hide Description Blood was collected in vacuum-sealed tubes designed to contain and preserve specimens in a manner appropriate for their respective analysis and shipped to Geneva Diagnostics for analysis using proprietary methodology (Oxidative Stress Analysis 2.0, Blood). Genova Diagnostics is a global, fully accredited clinical laboratory, located in Asheville, NC [Licensed by Clinical Laboratory Improvement Amendments (CLIA) Certification number #34D0655571]. This is another protective antioxidant enzyme measured from whole blood. The SOD enzymatic assay from Genova Diagnostics is designed to measure the activity of the SOD enzyme in the cytosol. The SOD assay is designed to measure the activity of SOD enzyme from whole blood. The SOD activity is determined spectrophotometrically based on the ability of the SOD compound to reduce reactive oxygen species in an enzymatic reaction necessary for the produc tion of an optically active compound.
Time Frame Baseline, 30 days, 57 days, and 88 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sugar Pill Protandim Dietary Supplement
Hide Arm/Group Description:
Corn starch and food coloring is the placebo comparator. Each subject ingested 675 mg (1 pill) per day of the placebo comparator
Each subject ingested 675 mg per day (1 pill) of Protandim for about 90 days. Each pill contains 5 botanicals (Bacoba extract 150 mg, milk thistle 225mg, ashwaganda 150 mg, green tea 75 mg, turmeric 75 mg).
Overall Number of Participants Analyzed 19 16
Mean (Standard Deviation)
Unit of Measure: U/g Hb x 1000
SOD, fasted, rest, baseline 11.7  (3.6) 11.4  (3.2)
SOD, rest, 30 (SD 2) days post-supplementation 14.1  (5.7) 15.3  (4.4)
SOD, rest, 57 (SD 2) days post-supplementation 11.3  (4.7) 9.9  (3.1)
SOD, rest, 88 (SD 4) days post-supplementation 18.7  (6.2) 20.0  (8.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sugar Pill, Protandim Dietary Supplement
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter week-to-week coefficient of variation %
Estimated Value 24
Estimation Comments This was the week-to-week coefficient of variation (CV) obtained at baseline over two different weeks in a fasted state measured at rest.
Time Frame Over a period of 3 months (88 days)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Sugar Pill Protandim Dietary Supplement
Hide Arm/Group Description Corn starch and food coloring is the placebo comparator. Each subject ingested 675 mg (1 pill) per day of the placebo comparator Each subject ingested 675 mg per day (1 pill) of Protandim for about 90 days. Each pill contains 5 botanicals (Bacoba extract 150 mg, milk thistle 225mg, ashwaganda 150 mg, green tea 75 mg, turmeric 75 mg).
All-Cause Mortality
Sugar Pill Protandim Dietary Supplement
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Sugar Pill Protandim Dietary Supplement
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/19 (0.00%)      1/19 (5.26%)    
Psychiatric disorders     
depression  [1]  0/19 (0.00%)  0 1/19 (5.26%)  1
Indicates events were collected by systematic assessment
[1]
The subject (female) claimed depression during the supplementation period. As such, she withdrew from the study
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Sugar Pill Protandim Dietary Supplement
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/19 (21.05%)      6/19 (31.58%)    
Gastrointestinal disorders     
Stomach ache  [1]  2/19 (10.53%)  2 5/19 (26.32%)  18
Diarrhea  [2]  1/19 (5.26%)  1 5/19 (26.32%)  10
Vomiting  [3]  1/19 (5.26%)  2 2/19 (10.53%)  2
Gas  [4]  4/19 (21.05%)  137 1/19 (5.26%)  51
Constipation  [5]  1/19 (5.26%)  8 2/19 (10.53%)  17
Nausea  [6]  2/19 (10.53%)  7 5/19 (26.32%)  17
General disorders     
Insomnia  [7]  0/19 (0.00%)  0 1/19 (5.26%)  1
Head Cold / Congestion  [8]  0/19 (0.00%)  0 1/19 (5.26%)  1
Metabolism and nutrition disorders     
Low Blood Sugar  [9]  0/19 (0.00%)  0 2/19 (10.53%)  18
Increased Appetite  [10]  1/19 (5.26%)  1 0/19 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Joint Pain  [11]  3/19 (15.79%)  6 2/19 (10.53%)  12
Nervous system disorders     
Headache  [12]  3/19 (15.79%)  12 6/19 (31.58%)  40
Drowsiness  [13]  4/19 (21.05%)  17 2/19 (10.53%)  3
Dizziness  [14]  2/19 (10.53%)  5 5/19 (26.32%)  33
Skin and subcutaneous tissue disorders     
Itching  [15]  0/19 (0.00%)  0 1/19 (5.26%)  8
Indicates events were collected by systematic assessment
[1]
Stomach Ache
[2]
Diarrhea
[3]
Vomiting
[4]
Gas
[5]
Constipation
[6]
Nausea
[7]
Insomnia
[8]
Head Cold / Congestion
[9]
Low Blood Sugar
[10]
Increased Appetite
[11]
Joint Pain
[12]
Headache
[13]
Drowsiness
[14]
Dizziness
[15]
Itching
  • Serum TBARS to detect lipid peroxidation is not specific.
  • TBARS may have been measured too quickly post-exercise.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Dr. Gerald S. Zavorsky
Organization: Georgia State University
Phone: 404-413-1271
Responsible Party: Gerald S Zavorsky, PhD, University of Louisville
ClinicalTrials.gov Identifier: NCT02172625     History of Changes
Other Study ID Numbers: 14.0614
First Submitted: June 20, 2014
First Posted: June 24, 2014
Results First Submitted: August 14, 2016
Results First Posted: January 9, 2017
Last Update Posted: January 9, 2017